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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
510(k) Number K122561
Device Name ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
Applicant
Ceremed , Inc.
3643 Lenawee Ave.
Los Angeles,  CA  90016
Applicant Contact CHELSEA MITCHELL
Correspondent
Ceremed , Inc.
3643 Lenawee Ave.
Los Angeles,  CA  90016
Correspondent Contact CHELSEA MITCHELL
Regulation Number874.3620
Classification Product Code
KHJ  
Date Received08/22/2012
Decision Date 11/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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